Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202212771733970 Date of Approval: 12/12/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title INFLUENCE OF SENSORY INTEGRATION TRAINING ON THE ‎SPATIO-TEMPORAL GAIT PARAMETERS IN PARKINSONIANS ‎FOLLOWING STEREOTACTIC SURGERY
Official scientific title INFLUENCE OF SENSORY INTEGRATION TRAINING ON THE ‎SPATIO-TEMPORAL GAIT PARAMETERS IN PARKINSONIANS ‎FOLLOWING STEREOTACTIC SURGERY
Brief summary describing the background and objectives of the trial Parkinson's Disease (PD) is a progressive, neurodegenerative disorder. It’s mainly ‎associated with dopamine innervation deficiency to the Corpus striatum (Nucleus ‎caudate and Putamen) and, as a consequence, PD symptoms’ appearance –motor ‎and non-motor. ‎ The major motor disturbances are resting tremors, rigidity, and akinesia (often ‎accompanied by postural instability and gait disorders), leaving an individual ‎unable to control or direct movement.‎ Gait difficulties have emerged as some of the main therapeutic challenges as they ‎impose substantial disability on PD patients, representing a milestone in the ‎progression of the disease. PD gait disturbance is produced by a combination ‎of multiple factors, including bradykinesia, impaired postural reflexes, ‎abnormal postures, rigidity, and tremor and characterized by a paucity of ‎movement of the trunk, upper-body, and lower-body muscles, resulting in ‎slow and shuffling steps that are short and rapid, which may lead to traumatic ‎injuries, and restriction of activities that in turn contribute to loss of ‎independence, and increased mortality.‎ The objective of this study is to examine the effect of sensory integration training (SIT) on gait parameters in PD ‎patients following stereotactic surgery
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial SENSORY INTEGRATION TRAINING
Anticipated trial start date 27/11/2022
Actual trial start date
Anticipated date of last follow up 30/06/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Traditional rehabilitation program ‎1-flexibility training for 10 min ‎2- strength training for 10 min ‎3- balance training for 10 min ‎4- treadmill for 10 min With a brief rest period in between Total traditional treatment 40 min/session for 12 weeks for 12 weeks 1-flexibility training: flexibility exercises ‎and stretching ‎2- strength training: progressive resistance exercise , mild-to-moderate ‎3- balance training: balance board ‎and Parkinson's-weight bearing exercise for better balance (PD-WEBB) exercise ‎ ‎4- treadmill for 10 min 15 Active-Treatment of Control Group
Experimental Group Seneori Integration Training ‎5 minutes , repeated 4 times with a brief rest in between (20 ‎minutes in total/session)‎ 12 weeks All participants will be standing on a platform of BBS with bare feet at the angle ‎between 25° and 30° degrees and supported both hands on the handrails. The ‎selected level of training is level eight of stability. Once the platform moves, we ‎will ask the participant to follow a set of targets through a maze. The participant ‎moves the cursor to each target as it blinks and don not let the cursor touch a wall ‎of the maze. The percentage of net good hits divided by the total target hits ‎determines the score, and any hits outside the boundary are subtracted from the ‎total target hits.‎ 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants that meet the following criteria will be included in the study: (1) ‎clinically diagnosed with Parkinson’s disease, who undergone stereotactic ‎surgery; (2) can stand for at least 30 min, without auxiliary equipment, and can ‎walk independently for 3 m or more; (3) aged between 60 and 70 years; (4) ‎exhibit stable condition, clear consciousness, can understand the content of the ‎scale, and cooperate with the examination and treatment; and (5) agree to sign an ‎informed consent form.‎ Participants who meet the following will be excluded from the study: (1) severe ‎gait disability with inability to walk unassisted; (2)neurological, vascular or ‎systemic disorders that may have caused permanent or intermittent weakness ‎or instability; (3)history of orthopedic hip or knee surgery which led to gait ‎difficulties; (4) Musculoskeletal or cardiopulmonary disorders that lead to ‎restricted mobility; (5)Neurological conditions other than PD; (6)Sensory system ‎pathology affecting walking or communication (e.g. blindness, deafness)‎ Aged: 65+ Year(s) 60 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/11/2022 Ethical Committee of Faculty of Physical Therapy Modern University for Technology and Information Cairo Egypt.
Ethics Committee Address
Street address City Postal code Country
El-hadaba El-Wosta, Mokatam, 5th district, Cairo, Egypt. Cairo 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Gait parameters:‎ Primary outcome measure will be most relevant spatio-temporal gait ‎parameters, including step length,cadence, gait velocity, and double stance ‎phase. They will be evaluated objectively through Tactile force and pressure ‎measurement system (Tekscan 〖Walkway〗^TMv. 7.02x) at the Gait ‎Analysis Laboratory in the faculty of physical therapy, Modern University ‎for Technology and Information.‎ pre-treatment and Post-treatment
Secondary Outcome ‎Functional mobility through:‎ Timed up and Go test TUG is a simple test to measure a person's level of mobility and requires static ‎and dynamic balancing skills. It measures the time and takes a person to get up ‎from a chair, walk three meters, turn around, return to the chair and sit down ‎again pre-treatment and Post-treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ElDemerdash.Hospital Ahmed Lotfy Al-Sayed street,Abbassyia,Cairo,Egypt Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Amir N Wadee 51 Toson St. Shobrea Cairo Egypt Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Amir N Wadee 51 Toson St. Shobra Cairo Egypt Cairo Egypt Individual
Secondary Sponsor Marwa Shafiek Mustafa saleh 10 Masarra St. Shobra Cairo Egypt Cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Amir N Wadee 51 Toson St. Shobra Cairo Egypt Cairo Egypt
Marwa Shafiek Mustafa saleh 10 Masarra St. Shobra CAiro Egypt Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amir N Wadee anazih@cu.edu.eg 01222367919 51 Toson St. Shobra Cairo Egypt
City Postal code Country Position/Affiliation
Cairo Egypt Professor of Physical Therapy Cairo University
Role Name Email Phone Street address
Public Enquiries Marwa Shafiek Mustafa saleh Marwa_shafiek2000@cu.edu.eg 01008342466 10 Masarrah St. Shobra Cairo Egypt
City Postal code Country Position/Affiliation
Cairo Egypt Associate Professor of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries AHMED IBRAHIM ABDELHAMED ibrahimabdelhamedahmed@gmail.com 01279107651 230 Orabi st. Shobra Cairo Egypt
City Postal code Country Position/Affiliation
Cairo Egypt 4th academic year physical therapy student
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Proposal will be submitted up to 36 months following article publication. After 36 months, the data will ‎be available in our university’ data warehouse but without investigator support other than deposited ‎metadata. Information regarding submitting proposals and accessing data will be found (link to be ‎provided)‎. Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information